Research Support Officer - Clinical Trial Coordinator Cancer

The UCC Cancer Trials Group (UCC CTG) is looking for a Clinical Trial Coordinator to support the Breast, Lung and Gynaecology cancer trials team at Cork University Hospital - Cancer Trials Cork Unit.

The Research Support Officer - Clinical Trial Coordinator is required to manage data in the department of Clinical Trials. He/she is responsible for the creation, updating, maintenance and validation of clinical study databases, and for the provision of computerised reports of these data. He/she is a key member of the clinical project team and should be able to prioritise and work in line with project management decisions. The responsibilities of the Research Support Officer - Clinical Trial Coordinator are to manage clinical trials through review, computerisation, cleaning and auditing of clinical data and databases in compliance with standard operating procedures and regulatory agency guidelines. The role of Research Support Officer - Clinical Trial Coordinator is to ensure the data is accurate and consistent before it is passed on to the study team for analysis which will determine the outcome of the trial. This role requires excellent communication and interpersonal skills, computer literacy, organisation and an awareness of time management.

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Project title: UCC Cancer Trials Group (Cancer / Cancer Trials

• Ensure Trial Compliance: Strictly adhere to all procedures, regulations, and ICH GCP standards in trial conduct, documentation, and storage.
• Proactive Quality Assurance: Identify and analyse recurring issues to implement corrective and preventative actions, promoting consistency and follow-through on all tasks.
• Essential Document Management: Coordinate the acquisition, distribution, and maintenance of all essential trial documentation.
• Accurate Data Integrity: Oversee patient eligibility checks, ensure protocol-required procedures are followed, and accurately transcribe data to CRFs from medical records, resolving data queries promptly to meet data lock deadlines.
• Safety Reporting & Audits: Facilitate timely reporting of Serious Adverse Events (SAEs) and distribution of SUSARs/line listings to regulatory bodies and actively assist with internal and external audits.
• Administrative & Site Coordination: Serve as a point of contact with Sponsors and other external collaborators, coordinate site initiation and close-out visits, manage trial supplies, and organize monitor visits.
• Training & SOP Maintenance: Contribute to staff/student induction, training, and mentoring, and assist in the updating and creation of unit Standard Operating Procedures (SOPs) to ensure current staff compliance.
• Operational oversight: Assist in the allocation of tasks to ensure staff are supported and protocol requirements are met accurately and on time.
• To provide specific research skills to support the on-going development of the research team and to contribute to the transfer of knowledge in the specific research area.
• To undertake research under the direction of a Principal Investigator or Head of Research Centre.
• To provide support in a specific area of expertise, including the use, maintenance and management of research, including equipment.
• To perform a variety of technical duties supporting the research project or programme, as required.
• To draw up detailed technical specifications as required.
• To support research project activities.
• To oversee installation of equipment, where required.
• To assist in setting up and maintenance of equipment, where required.
• To assist PI's and researchers in performing lab work, where required.
• To coordinate lab activity to support the research area/project where required.
• To develop contacts to acquire knowledge and understanding of the research project and research related work.
• To facilitate collaboration by liaising with other research groups within UCC and externally including industry projects.
• To develop and maintain a good working relationship with service departments in UCC.
• To co-ordinate day-to-day work to support the research project.
• To liaise with the Principal Investigator(s) and colleagues on matters relating to the research.
• To develop knowledge and understanding of the research project and research related work.
• To ensure compliance with Health and Safety procedures.
• To perform other duties related to the work described herein.

• A graduate qualification in a field or discipline relevant to the area of investigation i.e. BSc, MSc of PhD.
• Evidence of ongoing professional development.
• Previously worked in a Clinical Trial Organisation (essential)
• Clinical Trial Data Management experience (essential)
• Oncology Trial experience (essential)
• Proven experience working within Good Clinical Practice (GCP) and research regulatory guidelines (essential)
• Proven ability to identify recurring issues, analyse root causes, and propose/implement corrective actions is desirable.
• Proven experience of carrying out research in the relevant research speciality.
• Demonstrable achievements in delivering results.
• Ability to interact with stakeholders from a range of disciplines
• Excellent attention to detail.
• Excellent report writing and presentation skills.
• Capability of working effectively within a team to achieve results.
• Excellent organisational and communication skills.
• High level of initiative.
• Able to prioritise and deliver agreed objectives.
• Demonstrable knowledge of good clinical practice.
• Clinical research experience/interest in clinical research.
• Ability to work independently or as part of a team.
• Excellent verbal and written communication skills.